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Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

Primary Purpose

Exercise-induced Asthma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise challenge in a cold chamber
Methacholine challenge
Oil supplementation verum
Oil supplementation placebo
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Exercise-induced Asthma focused on measuring exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, oil supplementation, middle-chain and Polyunsaturated Fatty Acids

Eligibility Criteria

12 Years - 44 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent
  • Patients: Age ≥12 and 44 years
  • known exercise induced asthma
  • basic lung function FVC ≥ 75%, FEV1 ≥ 70%
  • decrease in FEV1 after exercise ≥ 15%

Exclusion Criteria:

  • lung function Forced vital capacity (FVC) <75% and Forced expiratory volume in 1 second (FEV1) <70%
  • chronic diseases or infections (e.g. HIV, Tbc)
  • pregnancy
  • systemic corticosteroid-treatment
  • inhalative corticosteroid therapy or leukotriene antagonists
  • alcohol, substance or drug abuse
  • smokers
  • inability to capture extend and consequences of the study

Sites / Locations

  • Goethe University Hospital Frankfurt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oil supplementation verum

Oil supplementation placebo

Arm Description

30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach ones daily 1190 mg of middle-chain and polyunsaturated fatty acids for four weeks. Before and after supplementation an exercise challenge in a cold chamber will be performed.

30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach placebo for four weeks. Before and after placebo treatment an exercise challenge in a cold chamber will be performed.

Outcomes

Primary Outcome Measures

Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo
The exercise challenge in cold air will be done on two timepoints. Before and after oil supplementation versus placebo supplementation. After exercise challenge spirometry will be measured. Decrease in FEV1 in verum and control group will be compared with t-test and Wilcoxon-Mann-Whitney-Test.

Secondary Outcome Measures

Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)
Comparison of decrease in eNO before and after supplementation in verum and placebo group
Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%)
Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group

Full Information

First Posted
March 18, 2015
Last Updated
September 2, 2016
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02410096
Brief Title
Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation
Official Title
Examination of Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation With Middle-chain and Polyunsaturated Fatty Acids in an Exercise-induced Asthma Provocation Model
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the bronchial inflammation and hyperresponsiveness after oil supplementation. Before and after oil supplementation the investigators measure decrease in lung function after exercise-challenge in a cold chamber and increase of inflammatory markers in the blood.
Detailed Description
Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest and show a decrease in lung function when they do sports or an exercise-challenge. In a previous study the investigators could show, that the combination of exercise test and inhalation of cold air ist more sensitive and specific than exercise-challenge in ambient temperature. It is known that omega - 3 -fatty acids could reduce the production of inflammatory mediators. In this study the investigators will investigate the protective effect of oil supplementation with middle-chain and polyunsaturated fatty acids in an exercise-induced asthma provocation model. Therefore the investigators will measure the decrease in lung function and a increase of inflammatory markers in the blood before and after oil supplementation. Before and after the exercise-challenge the investigators will measure spirometry and body plethysmography. The investigators want to examine if the body plethysmography is more sensitive in the measurement of exercise induced bronchoconstriction than spirometry. The investigators hypothesize that the oil supplementation can reduce bronchial inflammation and hyperresponsiveness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Asthma
Keywords
exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, oil supplementation, middle-chain and Polyunsaturated Fatty Acids

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oil supplementation verum
Arm Type
Active Comparator
Arm Description
30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach ones daily 1190 mg of middle-chain and polyunsaturated fatty acids for four weeks. Before and after supplementation an exercise challenge in a cold chamber will be performed.
Arm Title
Oil supplementation placebo
Arm Type
Placebo Comparator
Arm Description
30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach placebo for four weeks. Before and after placebo treatment an exercise challenge in a cold chamber will be performed.
Intervention Type
Other
Intervention Name(s)
Exercise challenge in a cold chamber
Intervention Description
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
Intervention Type
Other
Intervention Name(s)
Methacholine challenge
Intervention Description
Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Oil supplementation verum
Intervention Description
Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Oil supplementation placebo
Intervention Description
Patients and subjects will take double blind sunflower oil for four weeks
Primary Outcome Measure Information:
Title
Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo
Description
The exercise challenge in cold air will be done on two timepoints. Before and after oil supplementation versus placebo supplementation. After exercise challenge spirometry will be measured. Decrease in FEV1 in verum and control group will be compared with t-test and Wilcoxon-Mann-Whitney-Test.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)
Description
Comparison of decrease in eNO before and after supplementation in verum and placebo group
Time Frame
4 weeks
Title
Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%)
Description
Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Comparison of two methods of lung function testing as measured by spirometry (FEV1, percent predicted) and body plethysmography (specific airway resistance, sRAW, kPa*sec)
Description
Both methods will be done in parallel before and 4 times after exercise challenge in cold air. Afterwards the investigators can compare both methods and calculate the sensitivity for both methods to indicate exercise induced bronchoconstriction.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent Patients: Age ≥12 and 44 years known exercise induced asthma basic lung function FVC ≥ 75%, FEV1 ≥ 70% decrease in FEV1 after exercise ≥ 15% Exclusion Criteria: lung function Forced vital capacity (FVC) <75% and Forced expiratory volume in 1 second (FEV1) <70% chronic diseases or infections (e.g. HIV, Tbc) pregnancy systemic corticosteroid-treatment inhalative corticosteroid therapy or leukotriene antagonists alcohol, substance or drug abuse smokers inability to capture extend and consequences of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Schulze, MD
Organizational Affiliation
Johann Wolfgang Goethe University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goethe University Hospital Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19001792
Citation
Schubert R, Kitz R, Beermann C, Rose MA, Lieb A, Sommerer PC, Moskovits J, Alberternst H, Bohles HJ, Schulze J, Zielen S. Effect of n-3 polyunsaturated fatty acids in asthma after low-dose allergen challenge. Int Arch Allergy Immunol. 2009;148(4):321-9. doi: 10.1159/000170386. Epub 2008 Nov 11.
Results Reference
background
PubMed Identifier
22326606
Citation
Schulze J, Smith HJ, Fuchs J, Herrmann E, Dressler M, Rose MA, Zielen S. Methacholine challenge in young children as evaluated by spirometry and impulse oscillometry. Respir Med. 2012 May;106(5):627-34. doi: 10.1016/j.rmed.2012.01.007. Epub 2012 Feb 10.
Results Reference
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PubMed Identifier
22826043
Citation
Nensa F, Kotschy-Lang N, Smith HJ, Marek W, Merget R. Assessment of airway hyperresponsiveness: comparison of spirometry and body plethysmography. Adv Exp Med Biol. 2013;755:1-9. doi: 10.1007/978-94-007-4546-9_1.
Results Reference
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PubMed Identifier
19596563
Citation
Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.
Results Reference
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PubMed Identifier
511010
Citation
Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314.
Results Reference
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PubMed Identifier
2783477
Citation
Endres S, Ghorbani R, Kelley VE, Georgilis K, Lonnemann G, van der Meer JW, Cannon JG, Rogers TS, Klempner MS, Weber PC, et al. The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells. N Engl J Med. 1989 Feb 2;320(5):265-71. doi: 10.1056/NEJM198902023200501.
Results Reference
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PubMed Identifier
12904324
Citation
Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.
Results Reference
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PubMed Identifier
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Citation
Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.
Results Reference
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PubMed Identifier
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Citation
Dressler M, Fussbroich D, Bohler L, Herrmann E, Benker N, Tytyk M, Schulze J, Schubert R, Beermann C, Zielen S. Oil supplementation with a special combination of n-3 and n-6 long-chain polyunsaturated fatty acids does not protect for exercise induced asthma: a double-blind placebo-controlled trial. Lipids Health Dis. 2020 Jul 13;19(1):167. doi: 10.1186/s12944-020-01343-2.
Results Reference
derived

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Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

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